EUCTR2010-022338-10-IT进行中（未招募）1 期
Randomized Phase 2 Study of LY2157299 in Patients with Hepatocellular Carcinoma who Have Had DiseaseProgression on Sorafenib or Are Not Eligible to Receive Sorafenib - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have histological evidence of a diagnosis of HCC not amenable to curative surgery
- •[2] Child-Pugh Stage A
- •[3] Serum AFP =1.5 upper limit of normal (ULN)
- •[4] Have the presence of measurable disease as defined by the RECIST 1.1 (Eisenhauer et al. 2009; . A lesion that has been previously treated by local therapy will
- •qualify as a measurable or evaluable lesion if there was demonstrable progression following
- •locoregional therapy.
- •[5] Age >18 years
- •[6] Have given written informed consent prior to any study-specific procedures
- •[7] Have adequate organ function including:
- •- Hematologic: absolute neutrophil count (ANC) >1.5 x 109/L, platelets >75 x 109/L, and hemoglobin >8 g/dL
- •- Hepatic: bilirubin =2.5 times ULN); alanine aminotransaminase (ALT) and aspartate aminotransaminase (AST) <5ULN. Prothrombin time international normalized ratio, <2.3; or
- •prothrombin time, <6 seconds above control).
- •- Renal: Serum creatinine <1.5 times ULN or calculated creatinine clearance >45 mL/min
- •[8] Have a performance status of =1 on the Eastern Cooperative Oncology Group (ECOG) scale
- •[9] Have either:
- •- received sorafenib and have progressed or were intolerant to sorafenib, or
- •- are ineligible for sorafenib treatment (at the investigator’s discretion)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Are currently enrolled in, or discontinued within the last 28 days from a clinical trial involving an
- •investigational drug or device or not approved use of a drug or device, or concurrently enrolled in any
- •other type of medical research judged not to be scientifically or medically compatible with this study
- •[16] Known HCC with fibro-lamellar or mixed histology
- •[17] Presence of clinically relevant ascites
- •[18] History of liver transplant
- •[19] Have received >1 line of systemic treatment
- •[20] Have moderate or severe cardiac disease: (see Section 8.2)
- •[21] Have serious preexisting medical conditions that, in the opinion of the investigator, cannot be
- •adequately controlled with appropriate therapy or would preclude participation in this study
- •[22] Females who are pregnant or lactating.
- •[23] Have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in situ of the
- •cervix) unless in complete remission and off all therapy for that disease for a minimum of 3 years
- •[24] Have active infection that would interfere with the study objectives or influence study compliance
研究者
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